Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants...

AIMS: To assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in male and female patients with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS: In the MATRIX program,7213 patients were randomized to bivalirudin or UFH.Patients in bivalirudin group were subsequently assigned to receive or not to receive a post-PCI infusion.The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE),defined as death,myocardial infarction,or stroke,and net adverse clinical events (NACE),defined as MACE or major bleeding...

BACKGROUND: Although ticagrelor has improved clinical outcomes among patients with acute coronary syndrome compared with clopidogrel, adherence to this new antiplatelet agent in real-world practice has not been fully investigated. METHODS AND RESULTS: Between November 2011 and June 2014, 1278 of 4831 consecutive patients (26.5%) undergoing percutaneous coronary intervention at a tertiary care center were treated with ticagrelor. Premature ticagrelor cessation was categorized into (1) change, when ticagrelor was replaced by prasugrel; (2) de-escalation, when ticagrelor was replaced by clopidogrel; and (3) premature discontinuation, when ticagrelor was discontinued without P2Y12 inhibitor replacement...

AIMS: We aimed to evaluate the relationship between CT-based annular perimeter oversizing and the incidence of paravalvular aortic regurgitation (PAR) and permanent pacemaker (PPM) implantation in patients treated with the new self-expanding CENTERA transcatheter heart valve (THV) for severe aortic stenosis. METHODS AND RESULTS: 198 patients in the CENTERA-EU trial were stratified priori into four groups based on the perimeter oversizing (2.5%-10%, 10-15%, 15-20% and >20%)...

BACKGROUND: Predictors and clinical outcomes of stent thrombosis (ST) in women have not been well investigated. Present study aimed to identify predictors of definite ST and its impact on mortality in women undergoing percutaneous coronary intervention (PCI). METHODS: Patient-level data of women enrolled in 26 randomized trials of DES was pooled. The study population was stratified based on the presence or absence of definite ST. Cox proportional hazards models were used to determine the predictors of definite ST...

The publication of the Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) trial generated an immense amount of discussion, debate, and controversy.1 The editorialists posed in their title whether the ORBITA trial is the "Last nail in the coffin for PCI in stable angina?"2 The ensuing press coverage has been extensive, though mostly one-sided and largely following the negative tone set by the editorial. The exchange on social media has been at times vitriolic, both pro and con - the number of Tweets of the article (1716 as of February 25, 2018) now exceeds the number of patients enrolled by over seven-fold...

OBJECTIVE: To examine the prognosis of patients with cardiovascular and non-cardiovascular multimorbidity after acute coronary syndrome compared to patients without prior multimorbidity. METHODS: This multicenter prospective cohort study in Switzerland included 5,635 patients hospitalized with acute coronary syndrome between 2009 and 2014, with a one-year follow-up period. We defined cardiovascular and non-cardiovascular multimorbidity as having at least two prior comorbidities before the index hospitalization...

BACKGROUND: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs). OBJECTIVES: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator...

BACKGROUND: This study evaluated the views of the cardiology community on the clinical use of coronary intravascular imaging (IVI).Methods and Results:A web-based survey was distributed to 31,893 individuals, with 1,105 responses received (3.5% response rate); 1,010 of 1,097 respondents (92.1%) self-reported as interventional cardiologists, 754 (68.7%) with >10 years experience. Overall, 96.1% had personal experience with IVI (95.5% with intravascular ultrasound [IVUS], 69.8% with optical coherence tomography [OCT], and 7...

AIMS: This study evaluated the views of the cardiology community on the clinical use of coronary intravascular imaging (IVI). METHODS AND RESULTS: A web-based survey was distributed to 31,893 individuals, with 1,105 responses received (3.5% response rate); 1,010 of 1,097 respondents (92.1%) self-reported as interventional cardiologists, 754 (68.7%) with >10 years experience. Overall, 96.1% had personal experience with IVI (95.5% with intravascular ultrasound [IVUS], 69...

OBJECTIVES: This study sought to determine the impact of left ventricular diastolic dysfunction (LVDD) on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Left ventricular (LV) hypertrophy in response to afterload increase promotes the development of LVDD and represents an early stage in the progression to valvular heart failure. METHODS: In a consecutive cohort of 777 aortic stenosis patients undergoing TAVR, LVDD was categorized according to the latest guidelines...

OBJECTIVE: To assess the efficacy and safety of coronary left main (LM) disease interventions in patients with acute coronary syndromes (ACS) as compared to those without LM coronary artery disease. METHODS: A total of 2899 patients with ACS, enrolled in the prospective Swiss Program University Medicine ACS (SPUM-ACS) cohort, were included. The primary endpoints of independently adjudicated major adverse cardiovascular and cerebrovascular event (MACCE) and net adverse clinical event (NACE) were determined at 30-day follow-up...